Premarket Risk Management for New Medical Device Companies

If you're part of a new medical device company, this is a must-have book. As a complement to ANSI/AAMI/ISO 14971:2007/(R)2016 Medical devices-Application of risk management to medical devices, this book explains risk management concepts in practical terms for creating a compliant risk management file for a medical device.

You'll learn the risk management activities necessary to device design and development that need to be conducted prior to placing the device on the market. Your company will benefit from having well-structured evidence of risk management activities—necessary to support regulatory submissions, regulatory compliance audits, and compliance testing of the device.

Also included in this guide:

description of the contents of a risk management file

outlines of activities that go into the creation of a risk management file, such as hazard identification and risk asessment and control

templates for developing a risk management plan

checklist for creating a risk managment report

The goal of this book is for companies to take advantage of using risk management as part of the design thought process and to start it as early as possible. The benefit, in addition to a safe product, is fewer surprises late in development, which are very costly.